Guidance on how to apply for a conformity assessment certificate can be found in the document 'Application Instructions' below and in the Australian Regulatory Guidelines for Medical Devices (ARGMD) part 1 section 1 'Process to supply a medical device in Australia'.

As part of the conformity assessment application process, the manufacturer of a medical device is required to provide the 'Supporting data form' together with the supporting data of an application. The applicant should use either the single word version of the form OR the PDF version of the form with additional form pages as required.

Guidance

How to access a pdf or Word document

This document provides guidance on how to apply for a conformity assessment certificate.

• Web version of Application instructions: Conformity assessment certification
• Print version of Application instructions: Conformity assessment certification (pdf,445kb)

Forms

Conformity assessment certification - supporting data form

• Conformity assessment certification - supporting data form (pdf,419kb)
• Conformity assessment certification - supporting data form (Microsoft Word,186kb)

Additional pages

Note: The 'supporting data form' must only be provided to the TGA with the supporting data of the application after the applicant receives the acknowledgment email from the TGA for the lodged application in eBusinessServices. Only current forms will be accepted. Additional pages (e.g., for several facilities, devices, etc.) can be used as required.

Additional section 3.3: Manufacturer facility (site) details

• Conformity assessment certification - supporting data form additional section 3.3 (manufacturer facility details) (pdf,85kb)
• Conformity assessment certification - supporting data form additional section 3.3 (manufacturer facility details) (Microsoft Word,130kb)

Additional section 4: Critical supplier's details

• Conformity assessment certification - supporting data form additional section 4 (critical supplier's details) (pdf,86kb)
• Conformity assessment certification - supporting data form additional section 4 (critical supplier's details) (Microsoft Word,131kb)

Additional section 5: Device details - non-IVD devices only

• Conformity assessment certification - supporting data form additional section 5 (device details - non-IVD devices only) (pdf,118kb)
• Conformity assessment certification - supporting data form additional section 5 (Device details - non-IVD devices only) (Microsoft Word,132kb)

Additional section 6: IVD device details

• Conformity assessment certification - supporting data form additional section 6 (IVD device details) (pdf,89kb)
• Conformity assessment certification - supporting data form additional seciton 6 (IVD device details) (Microsoft Word,129kb)

Additional attachment 1 - New certificate checklist

• Conformity assessment certification - supporting data form additional attachment 1 - New certificate checklist (pdf,159kb)
• Conformity assessment certification - supporting data form additional attachment 1 - New certificate checklist (Microsoft Word,142kb)

Additional attachment 2 - Substantial change checklist

• Conformity assessment certification - supporting data form additional attachment 2 - Substantial change checklist (pdf,174kb)
• Conformity assessment certification - supporting data form additional attachment 2 - Substantial change checklist (Microsoft Word,138kb)

Additional attachment 3 - Recertification checklist

• Conformity assessment certification - supporting data form additional attachment 3 - Recertification checklist (pdf,94kb)
• Conformity assessment certification - supporting data form additional attachment 3 - Recertification checklist (Microsoft Word,131kb)